Automated Electronic Alert for the Care and Outcomes of Adults With Acute Kidney Injury

This randomized clinical trial evaluates the implementation of an automated warning system and its effect on the management and outcomes of acute kidney injury (AKI).


Efficacy evaluation
Effectiveness evaluation (primary and secondary outcomes) Primary outcome: the change value of eGFR after 7 days of random grouping; Estimated glomerular filtration rate changed within 7 days (Time Frame: within 7 days diagnosed with AKI) Secondary outcomes: seven-day mortality, 28-day mortality, 90-day mortality, 7-day dialysis, 28-day dialysis, 90-day dialysis, the rate of stage 2 AKI, the rate of stage 3 AKI, the rate of AKI recovery at discharge, the rate of AKI recovery at 90-day, the rate of timely-recognition of AKI, the interventions for AKI.

Statistical methods
Data were expressed as mean ± standard deviation (normal distribution) or median and quartile (non-normal distribution), and t-test or rank test was used for comparison between groups; categorical data were expressed by rate, and chi-square test was used for comparison between groups.Kaplan-Meier (KM) survival curve was used for survival data, and Log-rank test was used for comparison between groups.

Research Background
Acute kidney injury (AKI) is an important disease burden worldwide [1][2].About 13.3 million people worldwide suffer from AKI every year, 85% of whom live in developing countries; in addition, AKI causes 1.7 million deaths every year [3].The incidence of AKI in the hospital in developed countries is about 10%, and the incidence of AKI in China is about 1-9% [4][5].AKI not only greatly increases the risk of short-term death (2-3 times), but also greatly increases the risk of long-term renal dysfunction and cardiovascular and cerebrovascular events [2].
However, the timely diagnosis of AKI (diagnosed within 3 days) is not optimistic.At present, the diagnosis of AKI often relies on the changes of serum creatinine and the observation of urine output in a short period of time.However, in the early stage of AKI, there are often no obvious specific symptoms, so it is easy to miss the diagnosis.It is reported that the diagnostic registration rate of AKI in foreign countries is less than 50%, while the timely diagnosis rate of AKI in China is only about 30% [4].More importantly, at present, the creatinine value is only detected once during the hospitalization of most patients, so there may be a large number of missed diagnoses.Missed diagnosis will significantly increase the mortality of patients, delay the opportunity to prevent the deterioration of renal function.
In view of this, the International Society of Nephrology proposed the "0by25" initiative in 2013, with the goal of timely diagnosis and treatment of potentially reversible AKI, and reducing the preventable death of AKI to zero by 2025 [6].Our research group also investigated the incidence of AKI in hospitals in 2014, and the results showed that the incidence of AKI in hospitals was 1.6%, but only 44% were diagnosed in time, and the 30-day mortality rate was 35.3% [7].Therefore, it is urgent to improve the timely diagnosis of AKI!In addition to increasing clinicians' awareness of AKI, the international community is currently paying special attention to the establishment of an electronic alert system for early diagnosis of AKI [8].The AKI alert system is a program designed to automatically identify emerging serum creatinine values in the electronic medical record system.When the test system shows that the serum creatinine value increases by 50% or more than 26.5μmol/L compared with the patient's baseline (and the uremia patient is excluded), there will be an early warning of AKI to help doctors diagnose and treat early (see the figure below for the principle).However, whether the electronic alert system can improve the prognosis of patients with AKI has not yet reached a consensus [9].
The First Affiliated Hospital of Nanjing Medical University Based on the current status of AKI diagnosis at home and abroad, we have applied to the hospital and approved the proposal to establish a hospital AKI alert system.In April 2018, the AKI alert system has been tested, and currently ready to send text messages to clinicians.Therefore, we plan to design this randomized controlled study to observe the impact of acute kidney injury alert on patient care and prognosis.
We speculate that the early warning system for acute kidney injury in hospitals is expected to significantly improve the rate of timely diagnosis of acute kidney injury, reduce the use of nephrotoxic drugs, take early intervention measures such as blood volume supplementation, reduce the degree of kidney injury, and benefit the majority of hospitalized patients.If it is proven to be effective, it can be extended to large hospitals in the province and even the country, and ultimately significantly improve the quality of AKI diagnosis and treatment and reduce the burden of AKI in our country!

Study objective
Main objective: To observe whether the AKI early warning system can improve the medium and short-term human/renal survival of patients.
Secondary objective: To observe the impact of AKI early warning system on AKI intervention measures.1) Chinese male or female over 18 years old;

Study
2) AKI newly diagnosed by the AKI alert system; 3) There were no diagnoses of "uremia", "chronic kidney disease G 5 ", and "kidney transplantation" in the admission diagnosis.

Stages
serum creatinine standard 1 Creatinine increased by > 0.3mg/dl within 2 days or increased by more than 1.5-1.9times within 7 days 2 2.0-2.9 times the baseline value within 7 days 3 3.0 times the baseline value within 7 days b.Exclusion criteria: Any one of the following will not be included in this study: 1) Patients with known chronic kidney disease G5 (eGFR<15ml/min/1.73m2) or kidney transplantation; 2) AKI has occurred before the patient's alert of AKI;

c. Rejection criteria
The patient dies unexpectedly, such as in a traffic accident.Reasons: Considering that the cause of death of the patient has little to do with treatment.

grouping
Eligible AKI patients were randomly divided into AKI alert group and usual care group.In the alert group, the AKI alert system gave early warning; in the usual care group, the AKI alert system did not give early warning.
Design, Participants and Interventions 1. Study Design 1.1 Study design: single-center, double blind, parallel-group randomized controlled trial 1.2 Study participants a. Screening criteria: Patients must meet all of the following conditions:

1. 4
RandomizationRandom numbers were generated according to seed number 20180101, and patients were divided into 4 blocks according to surgical/internal medicine wards and ICU /non-ICU.Each block was divided into 2 groups on average.1.5 Intervention measures: AKI alert AKI alert is based on the KDIGO serum creatinine diagnostic criteria of AKI to determine whether the patient is AKI.When AKI is diagnosed, the hospital information system will send a text message to the physician in charge , which reads : "[Jiangsu Provincial People's Hospital] Friendly Reminder: Hello doctor, the patient in bed **, in the ** ward, admitted on **, has a serum creatinine result of ** from the ** test time.Based on the creatinine result, acute kidney injury is probable to occur.Acute kidney injury requires optimization of hemodynamics, discontinuation of unnecessary nephrotoxic drugs, and adjustment of antimicrobial drug dosage and dialysis if necessary.Please be vigilant and handle it accordingly.Thank you!For diagnosis and treatment inquiries, please contact the nephrology consultation service at the kidney consultation phone number**".If a patient experiences multiple episodes of AKI, the messages